Rebecca Wolfe Email & Phone Number

Boston, Ma, Us

Pittsburgh, Pennsylvania, Us

- Lead global strategy and execution of program management for multiple oncology assets. - Established program management function and governance infrastructure to enable efficient integrated development, program analyses, risk mitigation, cross-functional alignment, and decision making. - Guide teams to build program milestones, manage work plans and vendors, develop budgets, and ensure resources are aligned to meet program objectives. - Manage long- and short-term program activities, including schedule development, communication, status reporting, scenario planning and resource interactions.- Identify and resolve issues, proactively assess risks and develop mitigation, and communicate program status and issues to executive leadership team. - Establish and execute on program management processes and tools for integrated development planning, management, and execution. - Head due diligence and tech transfer of in-licensed oncology assets and out-licensing of biomarker panel.- Lead interactions with alliance partners, key consultants, and vendors.- Drive financial forecasting, budgeting and reporting across all departments. - Guide and execute business planning, drug development strategy, growth initiatives, and workforce planning as a member of the executive leadership team.- Hire, manage, and inspire the Program Management, Finance, Human Resources, Legal, Information Technology, and Quality teams.- Cultivate productive cross-functional communication and collaboration by fostering positive team dynamics, a strong, cohesive culture, and identifying opportunities for team development.

Facilitated, defined, and executed strategy and integrated development plans across compound programs and enterprise projects with clinical development, finance, and business development teams, as well as external partners. Led program management, including communication, data gathering, reporting, coordinating, and facilitating meetings, tracking, and resource management. Defined critical path and at-risk activities and interdependencies, anticipated bottlenecks, escalated and resolved issues, mitigated risks, established contingency plans, and cleared barriers to progress. Partnered with finance and functional units to budget, forecast, and manage cash flow. Coordinated CMC, Regulatory and Laboratory Sciences, IT, and Document Management teams. Optimized tech transfers so they were organized, accurate, and completed in a timely manner.

Indianapolis, Indiana, Us

Drove a transformative, cross-functional project and global implementation for site monitoring services and central monitoring services across three companies. Organized post implementation system stabilization, managed SaaS vendor, and created system-specific sustainable inspection readiness processes including risk mitigation. Ensured timely delivery of software releases thorough impact analyses, user acceptance testing, and job aid and training delivery.

Indianapolis, Indiana, Us

Led teams that executed projects with Six Sigma problem-solving methodology, removed and elevated project barriers, ensured integration with other business improvements, and gained alignment with varying senior leader stakeholders. Mentored Six Sigma Green Belts and Black Belts.Key Projects• Restructured database lock (DBL) processes across the portfolio. • Delivered Integrated Development Planning Project that drove reduction in white space from Candidate Selection through Phase III. • Integrated seven Clinical Laboratory Organization workshop deliverables into a holistic, end-to-end process.

Indianapolis, Indiana, Us

Provided direction, leadership, and technical and process expertise to Clinical Trial Managers supporting the Psychiatry and Pain Disorders team while exceeding deliverable timelines and outcomes.Select Highlights• Created quality plan for the compound program.• Directed program inspection readiness and guided team through complex audit responses and FDA site inspections.• Partnered with CROs to deliver on commitments by resolving issues and removing barriers.• Guided team capacity planning, compound termination decisions, and staff downsizing.• Sponsored and participated in Six Sigma Kaizens and Critical Chain builds.

Indianapolis, Indiana, Us

Lead Global Consultant for 33 country, 9,500 subject Diabetes CV outcomes trial involving two sponsors, two AROs, and one CRO. Created and delivered on implementation strategy for clinical trial plan, gained buy-in from global teams, and navigated complex legal, regulatory, and operational issues to drive trials forward.Built and motivated cross-functional teams to ensure quality, on-time, and on-budget deliverables were met. Integrated scientific, regulatory, and operational expertise to resolve complex issues with no pre-existing policies or procedures.Acknowledged in “Diabetes Care” and “Annals of Internal Medicine” publications for project management expertise.

Indianapolis, Indiana, Us

Identified, evaluated, and qualified potential investigators to drive trial enrollment with quality. Conducted site visits to ensure compliance to GCP, ICH | FDA guidelines, and company SOPs. Maintained inspection readiness at site and accountable for site-specific enrollment. Acted as Lead CRA across diabetes compound.

Indianapolis, Indiana, Us

Promoted diabetes product line and Evista to healthcare professionals, including thought leaders and internists.

Us

Developed, implemented, and evaluated medical nutrition care plans for patients.

Bachelor Of Science (Bs), Nutrition Sciences

Education record